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Cardiovascular DiseasesNCT02220582

Canadian Alliance for Healthy Hearts and Minds

An observational study of Cardiovascular Diseases, run by Montreal Heart Institute at 12 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Cardiac, Vascular and Cognitive Dysfunction (CVCD) Alliance will be a prospective, multi-ethnic cohort study in healthy Canadian individuals between 35 and 69, looking at contextual risk factors and novel predictors of hard events over a period of four years. Read more about this study

Who is it for?
Ages 35 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
What is being tested?
MRI
How many people
7,900 participants
Where
12 sitesCanada
Study dates
Nov 2013to Apr 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participants of Canadian Partnership for Tomorrow Project (CPTP) cohorts (BC Generations, Alberta Tomorrow Project, Ontario Health Study, CARTaGENE, Atlantic PATH) or non--CPTP cohorts (Montreal Heart Institute Biobank or the Prospective Urban-Rural Epidemiology, PURE study, or aboriginal cohort participants). Multi-ethnic participants including reserve-based Aboriginal peoples.

Who may be able to join

  • Informed Consent Form (ICF) was discussed, understood and signed by the participant
  • Participant is between ages 35 and 69 (inclusively) at time of screening
  • The participant is willing to undergo an MRI scan and all other required study procedures

Who cannot join

  • Participant has a known acute disease or condition that is considered serious in the investigator's opinion
  • Participant is claustrophobic and/or is known to suffer from moderate to severe anxiety during MRI scans or similar procedures
  • Participant is obese and/or exceeds equipment weight limit and/or circumference of the MRI portal at this of screening
  • Participant has any kind of metallic device that would contra-indicate Magnetic Resonance Imaging (MRI) (e.g. pacemakers, defibrillator, vascular clips, drug pumps, implant(s), or any other foreign bodies)
  • Participant has an extensive tattoo covering a large part of their chest or head
  • Female participants that are currently pregnant (confirmed or uncertain).
Show all 12Show fewer
  • Participants receiving Gadovist® only - Female participants that are currently breastfeeding.
  • Participants receiving Gadovist® only - Participant has a known hypersensitivity to gadolinium-based contrast agents
  • Participants receiving Gadovist® only - Participant has a known allergy or severe reaction to any contrast agent typically used in MRI procedures
  • Participants receiving Gadovist® only - Participant has known renal or hepatic impairment of any intensity or any other kidney/liver disease or has recently undergone kidney/liver transplant
  • Participants receiving Gadovist® only - Participant has a known glomerular filtration rate (eGFR or GFR) of 30 mL/min or less
  • Participants receiving Gadovist® only - Participant has taken part in a clinical research study or clinical study within 30 days prior to enrollment in this study, and/or received contrast agent within 72 hours prior to the study MRI

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Canada12 sites

  • Seaman Family MR Research Center

    Calgary, Alberta, T2N2T9

  • University of Calgary

    Calgary, Alberta, T2N4N1

  • QEII Health Sciences Center

    Halifax, Nova Scotia, B3H3A7

  • St. Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6

  • Robarts Research Institute

    London, Ontario, N6A1G9

  • Montreal Heart Insitute

    Montreal, Quebec, H1T 1C8

  • McGill University Health Center

    Montreal, Quebec, H4A3J1

  • Ottawa Heart Institute

    Ottawa, Ontario, K1Y4W7

  • IUCPQ

    Ste Foy, Quebec, G1V4G5

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N3M5

  • St Michael's Hospital

    Toronto, Ontario, M5B1W8

  • St Paul's Hospital

    Vancouver, British Columbia, V6Z1Y6

Other trials in Canada

About this study

Official title: A Pan-Canadian, Multi-ethnic Cohort Study in Healthy Participants Aimed to Better Understand the Impact of Individual, Socioeconomic and Other Environmental Factors Leading to Cardiac and Vascular Disease

The Cardiac, Vascular and Cognitive Dysfunction (CVCD) Alliance will be a prospective, multi-ethnic cohort study in healthy Canadian individuals between 35 and 69, looking at contextual risk factors and novel predictors of hard events over a period of four years.

The unique features of this initiative are:

  • MRI as the sole imaging technique (including the use of a mobile MRI machine)
  • Contextual factor analysis (including community environmental profile assessments)
  • Record linkage follow-up of individuals to health services (administrative) databases for major morbidity and mortality events and health services utilization
Read the detailed description

Cardiac, vascular, and cognitive dysfunction have a strong impact on the quality of life, longevity and health care costs, in Canada and globally. Cardiovascular risk factors account for up to half of the attributable risk for dementia, mediated in large part by difficult to detect microvascular disease of the brain. In this study the investigators will try to understand the role of the societal structure, nutrition, access to health services, and other socio-environmental and contextual factors on cardiovascular risk factors, subclinical disease and clinical cardiovascular events at the individual and population levels. We will try to identify markers for early subclinical dysfunction in the brain, vessels, heart and abdomen using magnetic resonance imaging and investigate the associations with contextual and individual determinants of these markers, as well as to assess the predictive value of novel markers of subclinical dysfunction on the development of clinical cardiovascular events.

Being tested
MRI
Keywords
Cardiac Magnetic Resonance (CMR), Cardiovascular Diseases, socio-environmental factors, Contextual factors
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIOther

    Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial Infarction (MI)

    Measured: After completion of MRI and during follow-up period (2 to 3 years)

  2. Stroke

    Measured: After completion of MRI and during follow-up period (2 to 3 years)

  3. Percutaneous Transluminal Coronary Angioplasty

    Measured: After completion of MRI and during follow-up period (2 to 3 years)

  4. Percutaneous Coronary Intervention

    Measured: After completion of MRI and during follow-up period (2 to 3 years)

  5. Coronary Artery Bypass Graft

    Measured: After completion of MRI and during follow-up period (2 to 3 years)

Secondary outcomes (3)

  1. Congestive Heart Failure

    Congestive Heart Failure requiring hospitalization

    Measured: After completion of MRI and during follow-up period (2 to 3 years)

  2. New onset established risk factors

    • Incident diagnosis of diabetes by physician
    • Incident diagnosis of arterial hypertension by physician
    • Incident diagnosis of significant cognitive dysfunction (i.e. dementia) by physician.

    Measured: After completion of MRI and during follow-up period (2 to 3 years)

  3. Risk markers acquired through imaging and blood samples

    • Acquired parameters that are linked to the present health status
    • Candidate parameters for predicting cardiovascular events which affect cardiac and cognitive dysfunction. For further details, please see list of outcomes in the questionnaires and the MRI protocol described in section 4 above

    Measured: After completion of MRI and during follow-up period (2 to 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2014 (estimated)
  2. Study startNov 2013
  3. Primary completionMay 2017
  4. Study completionApr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
7,900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02220582
Sponsor's protocol ID
CAHHM
Status last verified
Feb 2020
First submitted
18 Aug 2014
Last updated
21 Feb 2020
Results posted
No
Data monitoring committee
No

Publications

  • Luu JM, Gebhard C, Ramasundarahettige C, Desai D, Schulze K, Marcotte F, Awadalla P, Broet P, Dummer T, Hicks J, Larose E, Moody A, Smith EE, Tardif JC, Teixeira T, Teo KK, Vena J, Lee DS, Anand SS, Friedrich MG; CAHHM Study Investigators. Normal sex and age-specific parameters in a multi-ethnic population: a cardiovascular magnetic resonance study of the Canadian Alliance for Healthy Hearts and Minds cohort. J Cardiovasc Magn Reson. 2022 Jan 3;24(1):2. doi: 10.1186/s12968-021-00819-z.

    PubMed 34980185

  • Luu JM, Sergeant AK, Anand SS, Desai D, Schulze K, Knoppers BM, Zawati MH, Smith EE, Moody AR, Black SE, Larose E, Marcotte F, Kleiderman E, Tardif JC, Lee DS, Friedrich MG; CAHHM Study Investigators. The impact of reporting magnetic resonance imaging incidental findings in the Canadian alliance for healthy hearts and minds cohort. BMC Med Ethics. 2021 Oct 28;22(1):145. doi: 10.1186/s12910-021-00706-3.

    PubMed 34711210

  • Teixeira T, Hafyane T, Stikov N, Akdeniz C, Greiser A, Friedrich MG. Comparison of different cardiovascular magnetic resonance sequences for native myocardial T1 mapping at 3T. J Cardiovasc Magn Reson. 2016 Oct 4;18(1):65. doi: 10.1186/s12968-016-0286-6.

    PubMed 27716344

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases, run by Montreal Heart Institute at 12 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial Infarction (MI) (time frame: After completion of MRI and during follow-up period (2 to 3 years)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02220582, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.

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